XIX International AIDS Conference


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WEAB0203 - Oral Abstract Session

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-positive women

E.M. Kojic1, M. Cespedes2, T. Umbleja3, M. Kang3, J. Aberg2, R. Allen4, B. Grinsztein5, C. Firnhaber6, J. Webster-Cyriaque7, J.M. Palefsky8, C. Godfrey9, A.J. Saah10, S. Cu-Uvin1, ACTG 5240 Study Group

1Brown University - The Miriam Hospital, Infectious Diseases, Providence, United States, 2New York School of Medicine, New York, United States, 3Harvard School of Public Health, Boston, United States, 4ACTG Operations Center, Silver Spring, United States, 5Chagas Fiocruz, Rio de Janeiro, Brazil, 6University of Witwatersrand, Johannesburg, South Africa, 7University of North Carolina, Chapel Hill, United States, 8University of California at San Francisco, San Francisco, United States, 9NIAID NIH, Bethesda, United States, 10Merck Research Labs, North Wales, United States

Background: HIV-infected women are disproportionately affected by human papillomavirus (HPV)-related anogenital disease. A5240 is a clinical trial of 319 HIV-infected women at US, Brazil and South Africa sites to determine immunogenicity and safety of the quadrivalent HPV vaccine.
Methods: Safety and serostatus of HPV types 6, 11, 16, and 18 were examined in 222 women. The vaccine was administered at 0, 8, 24 weeks in 3 strata based on screening CD4: >350 (A), 201-350 (B), ≤200 cells/mm3 (C). HPV serotyping was performed using competitive Luminex Immuno-Assay (HPV-4 cLIA). HPV type-specific seroconversion analysis was on participants seronegative for the given type at baseline. Seroconversion was defined by: ≥20, ≥16, ≥20, ≥24 mMU/mL for types 6, 11, 16, 18 respectively. Two-sided 95% CIs are provided.
Results: We report preliminary safety and week 28 seroconversion results from A and B. At baseline, median age was 37 years (range 19-45), 13% were white, 57% black, and 29% Hispanic. Median nadir CD4 was 262 cells/mm3, 41% had undetectable HIV-1 viral load, 13% from non-US sites. No safety issues were identified; none of the grade ≥3 AEs was thought to be vaccine-related.Proportion of Women who Seroconverted 4 weeks After the Vaccination Series:

 HPV Type
Baseline seronegatives6111618
Stratum A CD4 > 350N=50N=79N=62N=73
Seroconversion proportion (95% CI)96% (86-99%)97% (91-100%)98% (91-100%)90% (81-96%)
Geometric Mean Titers (95% CI)425 (289-627)454 (337-611)1088 (777-1524)160 (114-225)
Stratum B 200<CD4 <350N=44N=55N=52N=66
Seroconversion proportion (95% CI)100% (92-100%)98% (90-100%)98% (90-100%)85% (74-93%)
Geometric Mean Titers (95% CI)324 (217-483)407 (277-600)1090 (722-1646)171 (114-257)

Conclusions: Quadrivalent HPV vaccine targeted at types 6, 11, 16, and 18 is safe and highly immunogenic in HIV-infected women 19-45 years old with CD4 >200.

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